This survey has been established to evaluate the effectiveness of prune and flixweed in prevention of constipation in 2010 hajj pilgrims. 145 persons in each group (case and control) will be enrolled and a form containing demographic data, history of drug use, history of previous disease and so on would be filled out by physician and those who have history of any systemic disease or drug consumption would be ruled out. In case group, 10 grams flixweed in 250 cc warm water and 50 grams prune would be distributed every morning 30 minutes before breakfast. We will continue trial 3 weeks and then evaluate patients' constipation base on ROME III criteria. A new form will be filled out in the end of trial based on different constipation parameters (pain on defecation, bleeding, feeling of incomplete defecation, frequency of bowel movement) as primary outcome and other gastrointestinal symptoms (distention, bloating, dyspepsia, abdominal pain and bowel sounds) as secondary outcome by visual analog score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009013074N2
Registration date:2011-04-17, 1390/01/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-17, 1390/01/28
Registrant information
Name
Mehdi Pasalar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7589
Email address
pasalar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Survey on Effectiveness of Descureania Sophia L. and Pronus Domestica L. for Prevention of Constipation in Haj Pilgrims in 2010: A Clinical Trial
Public title
A Survey on Effectiveness of Flex weed seeds and Prune for Prevention of Constipation in Haj Pilgrims in 2010: A Clinical Trial
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Registration in haj karavan under study. Exclusion criteria: a.Consumption of constipation forming drugs which couldn't disconnect them; b.Any gastrointestinal diseases like irritable bowel syndrome, Neurological diseases like Parkinson or Systemic diseases like diabetes mellitus ; c.Any gastrointestinal system surgery; d.Laxative drugs consumption during trial.
Age
From 20 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
In case group, 10 grams flixweeds in 250 cc water and 50 grams prune would be distributed every morning 30 minuets before breakfast. We will continue trial 3 weeks orally.
Category
Prevention
2
Description
There is no intervention in control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal Research Center
Full name of responsible person
Kamran Bagheri Lankarani
Street address
Shiraz
City
Mecca - Medina
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ,Shiraz University of Medical Sciences
Full name of responsible person
Dr.Hatam
Street address
Shiraz, Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research ,Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Pasalar
Position
MD
Other areas of specialty/work
Street address
Shiraz, Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 1230 5410
Fax
Email
pasalar@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Kamran Bagheri Lankarani
Position
MD
Other areas of specialty/work
Street address
Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 1230 5410
Fax
Email
lankaran@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Pasaar
Position
MD
Other areas of specialty/work
Street address
Zand Avenue
City
Shiraz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)